[No public or meaningful name is available]

Long-term toxicity to fish

Administrative data

Endpoint:

fish early-life stage toxicity

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Hazard assessment conclusion:

PNEC aqua (freshwater)

PNEC value:

47 µg/L

Assessment factor:

1 000

Extrapolation method:

assessment factor

PNEC freshwater (intermittent releases):

23 µg/L

Hazard assessment conclusion:

PNEC aqua (marine water)

PNEC value:

4.7 µg/L

Assessment factor:

500

Extrapolation method:

assessment factor

PNEC marine water (intermittent releases):

2.3 µg/L

Hazard assessment conclusion:

PNEC STP

PNEC value:

100 mg/L

Assessment factor:

10

Extrapolation method:

assessment factor

Hazard assessment conclusion:

PNEC sediment (freshwater)

PNEC value:

818 µg/kg sediment dw

Extrapolation method:

equilibrium partitioning method

Hazard assessment conclusion:

PNEC sediment (marine water)

PNEC value:

81.8 µg/kg sediment dw

Extrapolation method:

equilibrium partitioning method

Hazard assessment conclusion:

no hazard identified

Hazard assessment conclusion:

PNEC soil

PNEC value:

10 µg/kg soil dw

Assessment factor:

100

Extrapolation method:

assessment factor

Hazard assessment conclusion:

no potential to cause toxic effects if accumulated (in higher organisms) via the food chain

Fish embryo toxicity and short-term and long-term toxicity studies in Daphnia and algae are available on the test substance. Based on the short-term studies, the lowest EC50 value of 2.3 mg/L (measured) was identified from the Daphnia study and based on the two long-term studies, the lowest ErC10 value of 2.35 mg/L (measured) was determined from the algae study. Although the substance is not readily biodegradable, both acute and chronic effect concentrations are above 1 mg/L and therefore do not warrant an aquatic classification according to the EU CLP criteria (Regulation 1272/2008/EC).

Cross-reference 2

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Using the Arnot-Gobas BAF-BCF sub-model, the upper trophic BCF value for constituents was predicted to range from 0.893 to 590.50 L/kg ww (log BCF -0.05 to 2.77), leading to an weighted average value of 124.11 L/kg ww and indicating low bioaccumulation potential.

BCF (aquatic species):

591 L/kg ww

The bioconcentration factor (BCF) value for the test substance ‘mono- and di- C16-18 PSE and C16-18 AE10 PSE’ was estimated using the regression-based and/or Arnot-Gobas BAF-BCF methodology of the BCFBAF v3.01 program (EPI SuiteTM v4.11). Since the test substance is a UVCB, the bioaccumulation (BCF) values were estimated for the individual substances representative of the major components. Considering the structures of test substance, the regression-based equations as well as the Arnot-Gobas BAF-BCF methodology were used for the BCF predictions. Using the regression-based equations, the BCF values for the constituents were predicted to range from 3.16 to 1650 L/kg ww (log BCF 0.50 to 3.22) with weighted average value of 552.25 L/kg ww. While using the Arnot-Gobas BAF-BCF sub-model, the upper trophic BCF value for constituents was predicted to range from 0.893 to 590.50 L/kg ww (log BCF -0.05 to 2.77), leading to an weighted average value of 124.11 L/kg ww (US EPA, 2020). Therefore, considering that the constituents of the test substance are non-ionic and the BCF predictions from Arnot-Gobas method takes into account mitigating factors, like growth dilution and metabolic biotransformations, the BCF values from the Arnot-Gobas method has been taken into consideration from this model. Based on either the individual (0.893 to 590.50 L/kg ww) or weighted average (124.11 L/kg ww) predictions from the Arnot-Gobas method, the test substance can be considered to have a low bioaccumulation potential. On comparing with domain descriptors, one constituent for molecular weight and 3 out 12 constituents for log Kow did not meet the descriptor criteria as defined in the BCFBAF user guide of EPISuite. Therefore, overall, the BCF prediction for the test substance using BCFBAF model of EPI SuiteTM is considered to be reliable with moderate confidence.

Cross-reference 3

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

The critical micelle concentration (i.e., CMC, a water solubility equivalent for surfactants) of the test substance was determined by measuring the surface tension of a range of aqueous sample solutions of differing concentrations, according to OECD Guideline 115 and EU Method A.5 (Envigo, 2018).

Water solubility:

7 mg/L

at the temperature of:

20 °C

(based on CMC)

Cross-reference 4

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Type of CSR:

Own CSR (own uses)

CSR contains:

Part A

Part B section 1 to 8

Part B section 9 and 10

Chemical safety assessment/report tool used:

Chesar